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Abstract:

A device for controlling respiration during sleep, the device comprising:
an odor disperser adapted to disperse an odor; at lease one detector
adapted to detect a physiological characteristic of a user; a controller
configured for controlling respiration of the user by instructing the
odor dispenser to disperse an odor responsive to detections by the at
least one detector.

Claims:

1. A method of reducing the probability of snoring, the method
comprising: repeatedly dispersing an odor towards a sleeper during a
sleep period; reducing the probability of snoring of the sleeper by said
repeatedly dispersing odor.

2. A method according to claim 1, further comprising: monitoring
physiological characteristics of the sleeper during the sleep period.

7. A method according to claim 2, wherein at least one dispersion of said
repeatedly dispersing an odor is responsive to said monitoring.

8. A method according to claim 2, further comprising selecting an odor
for dispersion responsive to said monitoring.

9. A method according to claim 2, further comprising selecting a time
length of odor dispersion responsive to said monitoring.

10. A method according to claim 1, wherein reducing the probability of
snoring comprises reducing the probability of non-apnea snoring.

11. A method according to claim 1, wherein reducing the probability of
snoring further comprises preventing an apnea event.

12. A method according to claim 1, wherein reducing the probability of
snoring comprises reducing the probability of snoring without inducing
arousal.

13. A method according to claim 1, wherein reducing the probability of
snoring comprises increasing inhalation of at least one breath following
odor dispersion.

14. A device for reducing the probability of snoring during sleep, the
device comprising: an odor disperser adapted to disperse an odor; at
least one detector adapted to detect a physiological characteristic of a
user; a controller configured for reducing the probability of snoring by
the user by instructing the odor dispenser to disperse an odor responsive
to detections by the at least one detector.

15. A device according to claim 14, wherein the controller is further
configured for reducing the probabilty of snoring of the user over a
sleep period by repeatedly instructing the odor dispersion to disperse an
odor during said sleep period.

16. A device according to claim 14, wherein at least one detector is a
sound detector.

17. A device according to claim 14, wherein at least one detector is a
respiration detector.

18. A device according to claim 14, wherein the controller is further
configured for selecting an odor for dispersion.

19. A device according to claim 14, wherein the controller is further
configured for selecting a dose of odor for dispersion.

20. A device according to claim 14, wherein the controller is configured
to instruct odor dispersion, thereby preventing snoring by the user.

21. A device according to claim 14, wherein the controller is configured
to instruct odor dispersion, thereby preventing an apnea event by the
user.

22. A device according to claim 14, wherein the device can be worn as a
nose clip.

23. A device according to claim 14, wherein the device can be integrated
into a bed pillow.

24. A device according to claim 14, wherein the odors dispersed by the
odor disperser control respiration of the user only.

25. A method of controlling a device for reducing the probability of
snoring by a user during sleep, the method comprising: determining that
reducing the probability of snoring by odor dispersion is desired;
providing a device for odor dispersion; selecting a time period of odor
dispersion responsive to the reduction of probability of snoring
required; and activating the device.

26. A method according to claim 25, further comprising: selecting an
odorant for dispersion.

27. A method according to claim 25, wherein said selecting is responsive
to physiological measurements of a user.

28. (canceled)

29. A method according to claim 25, further comprising monitoring odor
influence on the user.

30. A method according to claim 29, wherein said selecting is responsive
to the monitored influence.

Description:

RELATED APPLICATION/S

[0001] This application claims the benefit of priority under 35 USC 119(e)
of U.S. Provisional Patent Application No. 61/282,233 filed on Jan. 5,
2010, the contents of which are incorporated herein by reference in their
entirety.

FIELD AND BACKGROUND OF THE INVENTION

[0002] The present invention, in some embodiments thereof, relates to
dispersing odor during sleep and, more particularly, but not exclusively,
to dispersing odor without inducing arousal.

[0003] The influence of odor on living beings has been greatly studied. A
number of studies have also researched the influence of odor on living
beings during sleep.

[0004] Badia et al (1990) assessed whether humans react to olfactory
stimuli presented in sleep. Badia et al found that peppermint
presentation of about 3 min to sleeping humans did not affect respiration
during these 3 min in comparison to other sleeping periods.

[0005] Marlier at al. (2005) showed that the introduction of a pleasant
odor in premature newborn's incubator is of therapeutic value in the
treatment of apneas unresponsive to caffeine and doxapram.

[0006] Seelke and Blumberg (2004) examined whether sniffing and arousal
are dissociable by presenting 8-day-old rats with dimethyl disulfide
(DMDS) while monitoring respiration and behavioral state. It was found
that sniffing, including polypnea, occurred while the rats were asleep.
Seelke and Blumberg also noted that presentation of DMDS did not evoke
reliable arousal responses in the sleeping rats.

[0007] Stuck et al (2007) found that the presentation of a strong but
selective olfactory stimulus does not lead to arousals during nocturnal
sleep in humans. In contrast, Stuck et al found that stimulation with a
selective trigeminal irritant, CO2, produced a concentration-dependent
increase in arousal frequency.

[0043] Rechtschaffen A, Kales A. 1968. A manual of standardized
terminology, techniques and scoring system for sleep stages of human
subject. Washington: US Government Printing Office, National Institute of
Health Publication.;

[0054] An aspect of some embodiments of the invention refers to
controlling respiration during sleep. In some embodiments, respiration is
controlled by repeated dispersion of odors. In some embodiments,
respiration is controlled in a manner which thereby stops or prevents
snoring and/or an apnea event. In some embodiment respiration is
controlled by reducing the probability of snoring and/or apnea during a
sleep period. Optionally, respiration is controlled to treat insomnia.
Optionally, respiration is controlled without inducing arousal.

[0055] According to an aspect of some embodiments of the present invention
there is provided a method of controlling respiration, the method
comprising:

[0056] repeatedly dispersing an odor towards a sleeper during a sleep
period;

[0057] controlling respiration of the sleeper by the repeatedly dispersing
odor.

[0058] According to some embodiments of the invention, the method further
comprises monitoring physiological characteristics of the sleeper during
the sleep period.

[0059] According to some embodiments of the invention, monitoring
physiological characteristics comprises monitoring respiration sounds.
According to some embodiments of the invention, monitoring physiological
characteristics comprises monitoring respiration movements. According to
some embodiments of the invention, monitoring physiological
characteristics comprises monitoring arousal. According to some
embodiments of the invention, monitoring physiological characteristics
comprises monitoring respiratory responses to the dispersing.

[0060] According to some embodiments of the invention, at least one
dispersion of the repeatedly dispersing an odor is responsive to the
monitoring.

[0061] According to some embodiments of the invention, the method further
comprises selecting an odor for dispersion responsive to the monitoring.
According to some embodiments of the invention, the method further
comprises selecting a time length of odor dispersion responsive to the
monitoring.

[0062] According to some embodiments of the invention, controlling
respiration comprises preventing snoring. According to some embodiments
of the invention, controlling respiration comprises preventing an apnea
event. According to some embodiments of the invention, controlling
respiration comprises controlling respiration without inducing arousal.
According to some embodiments of the invention, controlling respiration
comprises increasing inhalation of at least one breath following odor
dispersion.

[0063] According to an aspect of some embodiments of the present invention
there is provided a device for controlling respiration during sleep, the
device comprising:

[0064] an odor disperser adapted to disperse an odor;

[0065] at least one detector adapted to detect a physiological
characteristic of a user;

[0066] a controller configured for controlling respiration of the user by
instructing the odor dispenser to disperse an odor responsive to
detections by the at least one detector.

[0067] According to some embodiments of the invention, the controller is
further configured for controlling respiration of the user over a sleep
period by repeatedly instructing the odor dispersion to disperse an odor
during the sleep period.

[0068] According to some embodiments of the invention, at least one
detector is a sound detector. According to some embodiments of the
invention, at least one detector is a respiration detector.

According to some embodiments of the invention, the controller is further
configured for selecting an odor for dispersion. According to some
embodiments of the invention, the controller is further configured for
selecting a dose of odor for dispersion. According to some embodiments of
the invention, the controller is configured to instruct odor dispersion,
thereby preventing snoring by the user. According to some embodiments of
the invention, the controller is configured to instruct odor dispersion,
thereby preventing an apnea event by the user. According to some
embodiments of the invention, the device can be worn as a nose clip.
According to some embodiments of the invention, the device can be
integrated into a bed pillow. According to some embodiments of the
invention, the odors dispersed by the odor disperser control respiration
of the user only.

[0069] According to an aspect of some embodiments of the present invention
there is provided a method of controlling a device for controlling
respiration of a user during sleep, the method comprising:

[0070] determining that respiration control by odor dispersion is desired;

[0071] providing a device for odor dispersion;

[0072] selecting a time period of odor dispersion responsive to the
respiration control required; and

[0073] activating the device.

[0074] According to some embodiments of the invention, the method further
comprises to selecting an odorant for dispersion.

[0075] According to some embodiments of the invention, selecting is
responsive to physiological measurements of a user.

[0076] According to some embodiments of the invention, the device is a
device according to the aspect of some embodiments of the invention
described above.

According to some embodiments of the invention, the method further
comprises monitoring odor influence on the user. According to some
embodiments of the invention, selecting is responsive to the monitored
influence.

[0077] Unless otherwise defined, all technical and/or scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which the invention pertains. Although
methods and materials similar or equivalent to those described herein can
be used in the practice or testing of embodiments of the invention,
exemplary methods and/or materials are described below. In case of
conflict, the patent specification, including definitions, will control.
In addition, the materials, methods, and examples are illustrative only
and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

[0078] Some embodiments of the invention are herein described, by way of
example only, with reference to the accompanying drawings. With specific
reference now to the drawings in detail, it is stressed that the
particulars shown are by way of example and for purposes of illustrative
discussion of embodiments of the invention. In this regard, the
description taken with the drawings makes apparent to those skilled in
the art how embodiments of the invention may be practiced.

[0079] In the drawings:

[0080]FIG. 1 is a block diagram of a device for controlling respiration
in accordance with some embodiments of the invention;

[0081] FIGS. 2A-2C are schematic illustrations of integrations of the
device of FIG. 1, in accordance with exemplary embodiments of the
invention;

[0082] FIG. 3 is a flowchart of a method of controlling respiration by the
device of FIG. 1 in accordance with some embodiments of the invention;

[0083] FIG. 4 is a flowchart of a method of controlling respiration in
accordance with some embodiments of the invention;

[0084] FIG. 5 is a graphic illustration of pleasantness (A) and intensity
(B) scoring from the evening (before) and the morning (after) for the 4
odorants used in an experiment according to some embodiments of the
invention;

[0085] FIG. 6 is graphic illustration of (A) Frequency of arousals
associated with odor and baseline (clean air presented) in 4 odorants and
(B) Frequency of wake-ups associated with odor and baseline (clean air
presented) in 4 odorants used in an experiment according to some
embodiments of the invention;

[0086] FIG. 7 is a table of wake-ups and arousal occurrence during odorant
presentation and baseline in an experiment according to some embodiments
of the invention;

[0087] FIG. 8 is a graphic illustration of percent change from baseline in
the inhale/exhale volume ratio in 6 consecutive breathes following 1 of 4
odors used in an experiment according to some embodiments of the
invention;

[0088] FIG. 9 is a table of respiration volume during odor presentation
and baseline in an experiment according to some embodiments of the
invention;

[0089] FIG. 10 is a graphic illustration of breath inhale (A) and exhale
(B) volume in the first breath following odor onset (Y axis) and baseline
without odor (X axis) used in an experiment according to some embodiments
of the invention;

[0090]FIG. 11 is a graphic illustration of percent change from baseline
of the inhale/exhale volume ratio for 6 consecutive breathes following
odor onset performed in an experiment according to some embodiments of
the invention;

[0091] FIG. 12 is a graph illustration of probability of snoring with and
without odor dispersion performed in another experiment according to some
embodiments of the invention; and

[0092] FIG. 13 is a graph illustration of respiratory cycles of the
experiment of FIG. 12 according to some embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0093] The present invention, in some embodiments thereof, relates to
dispersing odor during sleep and, more particularly, but not exclusively,
to dispersing odor without inducing arousal.

[0094] An aspect of some embodiments of the invention relates to
controlling respiration during sleep, optionally without inducing arousal
or wake-up. In some embodiments, respiration is controlled by repeated
dispersions of odor.

[0095] As used herein, the term "repeated dispersion" refers to two or
more separate dispersions of odors during a single sleep period.
Optionally, two or more separate dispersion of odors during a single
sleep stage. Optionally, a sleep period is about 1-2 hours, or a night
sleep of between 6-10 hours, such as 8 hours. In some embodiments, the
delay between the beginnings of two consecutive dispersions of odors is
between 3-30 min, or any intermediate number, for example dispersion of
odor every 6, 9, 12 or 15 min. In some embodiments, each dispersion
occurs for between 1-30 seconds, for example for 5, 10 or 20 seconds.
Optionally, repeated dispersion refers to between 10-40, such as between
20-40, 15-35 or 20-30 dispersions of odor during a night sleep.
Optionally, repeated dispersion continues till waking up of the user.

[0096] The inventors of the present application have found that repeated
inhalation of odors during sleep may be used to control respiration. For
example, the inhalation of certain odors decreases inhalation volume and
increases exhalation volume, for several breaths, without inducing
arousal or wake-up. The inventors have found that repeated application of
odor dispersion can change a respiratory pattern during sleep without
inducing arousal or wake-up

[0097] As used herein, "controlling respiration" refers to influencing a
respiratory pattern. In some embodiments, controlling respiration refers
to maintaining respiration within a range, for example a range of
breathings within a time period or range of volume of breathings.
Optionally, maintaining respiration within a range is achieved by
dispersing odors when respiration is out or almost out of the range.
Alternatively or additionally, controlling respiration refers to
preventing certain respiratory events, such as respiratory events that
are considered as disturbing or dangerous, for example, snoring, choking
or breathing suspensions. Optionally, preventing respiratory events is
achieved by dispersion of odors when such respiratory events occur or are
about to occur. For example, controlling respiration may refer to
reducing snoring during a sleep period

[0098] In some embodiments, controlling respiration refers to control of
respiratory sounds during sleep, such as sounds in the throat or nasal
cavities; For example, preventing or stopping snoring by changing the
respiratory pattern, optionally by dispersion of odors. In some
embodiments, controlling respiration refers to treating breathing
suspensions, such as by enforcing breathing; For example, enforcing
respiration, optionally by odor dispersion, when an apnea event has
started or when the sleeper is choking.

[0099] In some embodiments of the invention controlling respiration refers
to influencing upcoming breathings, for example decreasing inhalation in
one or more breath following odor dispersion. In some embodiments of the
invention controlling respiration refers to influencing the probability
of respiratory events during a sleep period. For example, reducing the
probability of snoring or apnea during a sleep period, optionally by
between 30%-70%, such as by about or more than 40%, 50%, 60% or more.

[0100] As used herein, arousal and wake-up are defined as known in the
art. In some embodiments of the invention, arousal is defined by an
abrupt change in Electroencephalogram (EEG) frequency and/or a brief
increase in Electromyogram (EMG) for more than 3 seconds. In some
embodiments of the invention, wake-up is defined by an abrupt change in
Electroencephalogram (EEG) frequency and/or a brief increase in
Electromyogram (EMG) for more than 15 seconds. These definitions of
arousal or wake-up are defined by the atlas task force of the American
Sleep Disorder Association (AAoSTMF 1992). Other definitions of arousal
and/or wake-up may be used according to embodiments of the present
invention, for example by measuring increase in EMG alone, or by
measuring electrocardiogram (ECG).

[0101] In some embodiments, respiration is controlled by inducing arousal.
For example, if dispersion of odor did not change the respiratory pattern
as expected, arousal may be induced. Optionally, arousal is induced by
dispersion of odor. Alternatively or additionally, arousal is induced by
sound or vibration. In some embodiments of the invention, a short arousal
may be induced and is not considered as disturbing or interrupting a
sleep period. For example, arousal of about 5-10 seconds may be induced
to change a respiratory pattern, and does not significantly disturb
sleep.

[0102] In some embodiments of the invention, odors are dispersed at
predefined time frames. Optionally, the time frames are equally apart
from each other, such as every 3, 6 to or 9 minutes. Alternatively, the
odor is dispersed at random time frames. In other embodiments, odors are
dispersed responsive to a respiration event or to a number of respiratory
events. For example, odors may be dispersed responsive to sounds, such as
snoring sounds or responsive to no sounds, such as when there is a
breathing suspension. In some embodiments, odors are dispersed at random
or predefined time frames and in addition responsive to respiration
events.

[0103] Alternatively or additionally, odors are dispersed at time frames
based on a history of respiratory responses or respiratory events of a
sleeper. For example, when a respiratory event is known to occur every
certain time, odors may be dispersed at or before the expected time of
event. Alternatively or additionally, odors are dispersed according to
rate of recovery of inhalation volume; For example, dispersion of odor is
repeated when inhalation volume is recovered by about 50%.

[0104] In exemplary embodiments, one or more of the dispersed odors do not
induce arousal or wake-up. In some embodiments, one or more of the
dispersed odors have only an olfactory effect. In other embodiments, one
or more of the dispersed odors are trigeminal, having a nervous effect as
well or instead. Optionally, one or more of the dispersed odors are mild
trigeminal and/or are provided in a small enough dosage to do not induce
an arousal or wake-up response. Optionally, the same odor is dispersed
during a single sleep period. Alternatively or additionally, different
odors are dispersed at different time frames during the sleep period.
Alternatively, one or more mix of odorants is dispersed at different time
frames.

[0105] In some embodiments, the dose (or concentration) of odor dispersed
is pre-defined and constant. In other embodiments, the dose of odor is
randomly defined. In other embodiments, the dose of odor is dynamically
changeable for example responsive to increase in arousal levels or
responsive to respiration events. For example, increase in dose when
snoring occurs or decrease when no specific respiration event is
detected. In some embodiments each odorant has a threshold upon which it
may induce arousal or wake-up and/or a threshold at which it induces a
desired respiratory response. Optionally, doses above such thresholds are
avoided.

[0106] In some embodiments, an odor's changing effect on respiration is
measured during the sleep period and the type, dose and time of odor
dispersed is adapted accordingly. For example, in order to compensate for
user adaptation to the odor or for to room saturation the dose of odor
may be increased over time or the type of odor may be changed.

[0107] An aspect of some embodiments of the invention relates to a device
for controlling respiration during sleep. In some embodiments, the device
is operative to release odors at certain time periods. Optionally, the
device includes one or more detectors for detecting physiological
measurements and/or sleep characteristics such as noise, respiration,
sleep stage and more. Optionally, the device releases odors responsive to
detections by the detectors, for example responsive to detected noises.

[0108] In some embodiments, the odors released by the device do not induce
arousal or wake-up. Optionally, some of the odors released by the device
do induce arousal and are used following an odor dispersion that did not
reach a desired effect. Alternatively or additionally, other arousal
inducers are used, such as alarm.

[0109] In some embodiments of the invention, the device can be integrated
with existing devices, such as bed lamp, pillow, garments, bedding, bed
table, radio, alarm clock, etc. Optionally, the device can be used in
other embodiments than bed sleep, for example in a car or lecture, when a
person is snoring and disturbing others.

[0110] In some embodiments of the invention, the device is designed to
release odors near, at (or in) the nose of the sleeper. Optionally, the
odors are dispersed without causing discomfort to others located near the
sleeper, such as a spouse. Optionally, the dispersed odors do not control
respirations of other located near the sleeper. Optionally, the dispersed
odors are sensed by others located near the user but are insufficient to
affect respiration of others.

[0111] In some embodiments, the device comprises a controller for
controlling the release of odors, optionally in order to control
respiration of the user. Optionally, the controller controls the time
frames at which odors are released. Optionally, the controller controls
the dose of odor released. Optionally, the controller controls the type
of odor released. Optionally, the controller controls the length of each
odor release.

[0112] In some embodiments, the device comprises a table of odorants and
their affect on user's respiration, optionally according to dose and/or
sleep stage. Optionally, the table is updated during activation of
device, for example after a number dispersion or after a predefined time.
In some embodiments, the controller is programmable according to to a
number of rules by which it can control. For example, rules such as
dispersion of odors at predefined time frames and/or predefined doses
and/or predefined lengths. Optionally, the rules are selected responsive
to the information in the table. Alternatively or additionally,
calculation is performed to select a rule responsive to the information
in the table and/or other information detected.

[0113] In some embodiments the controller is connected to the one or more
detectors and controlling is performed responsive to inputs received from
the one or more detectors.

[0114] In some embodiments, the device is manually controllable by a user.
For example, the device may include a timer for activating the device for
a certain time period, which can be set by a user. Optionally, the device
automatically detects sleep and wake-up of the user and operates when the
user is sleeping or during a certain sleep stage. Optionally, the device
detects sleep by any of lack of movement in the room, snoring sound,
entry into bed or light turn off. Optionally, wake-up is detected by
movement of the user (i.e. getting out of bed), by alarm tune or
according to breath detection. In some embodiments, a user may manually
set the dose and/or type of odor dispersed. In some embodiments, a
practitioner may define odor dispersion by the device in accordance with
an ongoing treatment for a sleeper.

[0115] Before explaining at least one embodiment of the invention in
detail, it is to be understood that the invention is not necessarily
limited in its application to the details of construction and the
arrangement of the components and/or methods set forth in the following
description and/or illustrated in the drawings and/or the Examples. The
invention is capable of other embodiments or of being practiced or
carried out in various ways.

[0116] Referring now to the drawings, FIG. 1 is a block diagram of a
device 100 for controlling respiration during sleep, showing various
optional features as well. Device 100 includes an odor generator 110
which is connected to an odorant reservoir 105 and is adapted to generate
one or more odors. In some embodiments, odorant reservoir 105 includes
one or more odors, for example, 1, 2, 3, 4, 5, 6 or more odors.

[0117] Optionally, the odorants in reservoir 105 are olfactory odorants,
such as vanillin and ammonium sulfide. Alternatively or additionally,
reservoir 105 includes trigeminal to odorants, optionally mild trigeminal
odorants which do not induce arousal or wake-up, for example lavender oil
and vetiver oil. Optionally, one or more of the odorants in reservoir 105
do not induce arousal or wake-up response at stage 2 or slow wave sleep.
Optionally, one or more odorants in reservoir 105 reduce arousal or
wake-up responses, in stage 1 sleep or in any sleep stage. Optionally,
one or more odorants in reservoir are considered pleasant odorants such
as vanillin, lavender or perfume. Optionally, one or more odorants in
reservoir 105 are considered unpleasant odorants, such as ammonium
sulfide, vetiver oil or rotten food.

[0118] In some embodiments a scale of pleasantness is provided with signs
(such as olfactory or trigeminal) and a user (or practitioner) can choose
along scale and of different signs.

[0119] In some embodiments, one or more odorants in reservoir 105
temporarily modify respiration when inhaled during sleep. Optionally,
inhalation of one or more odorants in reservoir 105 provide a respiratory
rejection type response such as decreased inhalation for several breaths
after odor onset, for example between 1-10 breaths, such as for 3, 4, 5,
6, 7 or 8 breaths. Optionally, inhalation of one or more odorants in
reservoir 105 provide a respiration response of increased exhalation for
several breaths after odor onset, for example between 1-10 breaths, such
as 1, 2, 3, 4, 5 or 6 breaths. In some embodiments, odor dispersion
provides a decrease of between 20%-40%, such as about 30% in nasal
inhalation/exhalation volume ration in the first breath after odor onset.
Optionally, one or more odorants in reservoir 105 may change a balance
between nasal and oral breathing, such as to increase nasal breathing.
For example, odor dispersion may increase nasal exhalation, reflecting an
increase in oral inhalation.

[0120] For example, inhalation of vanillin may reduce nasal
inhalation/exhalation volume ration for about 27% at the first breath
after odor onset, a volume which linearly decreases till about 5% at the
sixth breath after odor onset. That is, the inhalation volume may
decrease with about 23% and the exhalation volume may increase with about
6% at the first breath after vanillin dispersion.

[0121] In some embodiments, the odors in reservoir 105 are stored (or
pre-pressurized) in a capsule or can. Optionally, the odors are in liquid
form which evaporates or is pumped out of the can. Alternatively, the
odors are in solid form and sublimate when released from the capsule or
can. Optionally, the odors are stored in hermetically sealed to capsules
or cans having a nozzle and a threaded end which can be screwed to the
odor generator. Optionally, the odorants are sold at any pharmacy.

[0122] In some embodiments, a capsule or can including a plurality of
odorants can be acquired by a user, for example as a test kit. The user
may then decide to acquire only specific odorants or type of odorants for
further use. Optionally, the user may order a capsule or can including a
plurality of odorants.

[0123] Odor generator 110 is adapted to generate odorants from the odors
in reservoir 105. Optionally, the odors are generated from molecules or
blends of odorants in reservoir 105. Optionally, the odors are generated
from a mix of odorants in reservoir 105. In some embodiments, each
odorant in reservoir 105 is connected by a tube to an optional mixer 108.
Optionally, each tube also includes a valve (optionally controllable by
controller 130) for regulating the desired dose of odorant. Different
doses may be used for each odorant. The odorants are then optionally
mixed in mixer 108 as known in the art. For example, if the odorants are
solid, the mixer may blend the odorants. Alternatively, if the odorants
are in liquid form, the mixer may shake the odorants. Mixer 108 may then
transfer the mixed odors to generator 105. Alternatively, mixer 108 is
situated in generator 105.

[0124] Optionally, the mixed odors are of the same type (olfactory or
trigeminal). Alternatively, types of odors are mixed in the generated
odor. Optionally, the mixed odors comprise both pleasant and unpleasant
odors. Alternatively, the mixed odors comprise only pleasant or
unpleasant odors. Optionally, a mix of unpleasant odors may result in a
pleasant odor or vice versa.

[0125] Odor generator 110 is connected to a nozzle 120 which releases the
odors. Nozzle 120 is optionally connected to a regulator such as a valve
or dosemeter 115 for regulating the dose of odor dispersed. Optionally,
the odors are released as a puff of air, optionally by use of a pump.
Alternatively, a block of odorant is embedded within an airflow which is
constantly released from nozzle 120. For example, odor can be mixed with
air, resulting in an odor concentration of about 40%, 50%, 60% or more in
the dispersed air. Alternatively, 100% of odor concentration is
dispersed. Optionally, the regulator is an air dilution olfactometer,
which is optionally computer-controlled. For example, an olfactometer as
described in Sobel et al. 1997 or Johnson and Sobel, 1997, the
disclosures of which are incorporated herein by reference. Optionally, a
computer can control change in odor volume and/or odor concentration.
Alternatively or additionally, the regulator is manually adjustable by a
user or by a practitioner.

[0126] In some embodiments, valve 115 (or a pump at the odor source)
provides an odor environment in which odors are not constantly dispersed
but rather onset and offset of odorant delivery are perceived. In these
embodiments, odor onset is designed to provide a change in odor
concentration and to be sensed by the sleeper and optionally affects a
respiratory pattern. In some embodiments, positioning valve 115 near
nozzle 120 provides for better control of odor dispersion.

[0127] Nozzle 120 is optionally positioned near the nose of a sleeper
which will inhale the odors. In some embodiments, nozzle 120 is directed
towards the sleeper such that the dispersed odors will not cause
discomfort to others located near the sleeper, such as a spouse sleeping
near the sleeper. Optionally, the dispersed odors do not control or
affect respiration of others located near the sleeper. In some
embodiments, other located near the user sense a significantly lower dose
of dispersed odors than sensed by the sleeper for which the device is
designated. Optionally, only between 5%-50%, or less, of the released
odors are sensed by others located near the user, for example only 10% or
20%. Optionally, the connection between nozzle 112 the odor generator or
mixer is between 1 cm-2 meters, for example about 2 cm, 5 cm, 10 cm or
1-2 meters.

[0128] Optionally, nozzle 120 is positioned such that the odors are
released in the nose of the sleeper. In some embodiments, nozzle 120 can
be worn as a clip on a nose, a tube at or in the nose or as a nasal mask.
Optionally, the nozzle is in the form of a clip which can be attached to
headboard or pillow. In general, the distance of nozzle 120 from the nose
of the user is a function of odor dosage, i.e. if the nozzle is
positioned 1 cm from the nose of the user, a smaller dose of odor is
needed than when the nozzle is positioned further away, such as 10 cm or
more from the nose of the user. Different integrations of nozzle 120 are
shown in FIGS. 2A-2C and described below.

[0129] Device 100 further optionally comprises one or more detectors 140
for detecting physiological measurements and/or sleep characteristics. In
some embodiments, detector 140 detects sounds, such as sounds from the
throat or the nasal which may indicate snoring or choking at certain
noise levels. Optionally, detector 140 monitors breathing sounds.
Optionally, the breathing sounds are recorded and analyzed using a sound
data to processing and recognition method. The device may thereby detect,
any case of un-normal breathing event, for example breathing suspensions
or snoring. In some embodiments, detector 140 detects the volume of
breathing, such as shallow or deep breathings. In some embodiments,
detectors 140 detect arousal or wake-up response, for example by
electrodes that measure EEG and/or EMG. In some embodiments, detectors
140 detect the occurrence of an apnea event. In some embodiments,
detector 140 is a breathing sensor which senses respiratory movements. In
some embodiments, detector 140 detects at what sleep stage the sleeper
is, for example by electrodes attached to the sleeper's head. In some
embodiments, the detector detects blood oxygation and is optionally worn
as a finger clip. Other detectors known in the art may also be used.
Optionally, device 100 includes a plurality of detectors of different
types.

[0130] Odor generator 110 and nozzle 120 are optionally connected to a
controller 130. Controller 130 commands odor generator 110 to generate
odors or a mix of odors and the dispersion of the generated odors by
nozzle 120, optionally in order to control respiration of the user.

[0131] FIG. 3 is a flowchart of a method 300 of instructing odor
generation and dispersion by controller 130, in accordance with some
embodiments of the invention. In some embodiments, method 300 is not
performed by a controller but manually, for example by a practitioner,
such as a practitioner of method 400 described below.

[0132] At 310 controller 130 determines that an odor dispersion is
necessary.

[0133] In some embodiments, controller 130 determines the necessity of
odor dispersion according to predefined time frames. For example,
controller 130 may determine the necessity of odor dispersion between
every 3-30 min, for example every 6, 9, 12 or 15 min optionally,
controller determines the necessity of odor dispersion according to count
of breaths, which is optionally limited to a number of breaths per
minute. Optionally, controller 130 randomly determines the necessity of
odor dispersion.

[0134] In some embodiments, controller 130 receives inputs from one or
more detectors 140 and determines the necessity of odor dispersion
responsive to the received inputs from detector 140. For example,
controller 130 may determine that odor dispersion is necessary responsive
to a detection that the user is sleeping or has reached a certain sleep
stage.

[0135] Controller 130 optionally instructs odor dispersion so as to
control respiration of to the sleeper. For example, the controller may
instruct odor dispersion so as to maintain respiration within a range,
for example a range of breathings within a time period or range of volume
of breathings. For example, detectors 140 may detect number of breathings
of the user and when the breathings are out or almost out of the range,
controller 130 may instruct odor dispersion, i.e. shallow breath will
increase the number of breaths in the range while deep breaths will
decrease them. Alternatively or additionally, controller 130 instructs
odor dispersion so as to prevent certain respiratory events, such as
respiratory events that are considered as disturbing or dangerous, for
example, snoring, choking or breathing suspensions. Optionally, only
respiratory events at a certain range or frequency are treated.
Optionally, one or more of detectors 140 detect the occurrence of such a
respiratory event and controller 130 instruct odor dispersion responsive
to the detection. For example, when detector 140 is a sound detector,
detected sounds from the nasal may indicate snoring, which can be stopped
by dispersion of odors. In addition, detection of deep breath (or
increase in inhalation) may indicate that the user is about to snore and
odor dispersion may be instructed. In addition, detection of no breathing
sounds may indicate an apnea event which can also be treated by
dispersion of odors. Alternatively or additionally, one or more detectors
140 detect that such a respiratory event is about to occur, for example
by detecting deep or shallow breathings, and controller 130 instructs
odor dispersion in order to prevent the occurrence of such a respiratory
event. For example, when treating insomnia, detector 140 may detect that
the user is about to arouse, for example by detecting that the sleeper
has moved from slow wave sleep to REM sleep, or has already aroused and
instruct odor dispersion. Optionally, the dispersed odors control an
average volume of breath, by providing odorant more or less frequently.

[0136] Controller 130 may instruct a single odor dispersion or a cycle of
odor dispersions. For example, responsive to a breathing suspension that
occurred 10 min after the latest odor dispersion, controller may decide
that odor should be dispersed every 9 min or less.

[0137] In some embodiments of the invention controller 130 controls
respiration by instructing dispersion to influence upcoming breathings.
For example, controller controls a sequence of between 1-6 breathings to
be without snoring. The controller receives inputs of the respiratory
status of the user and instructs dispersion in response. For example, to
treat an apnea event, to treat snoring or choking, etc. Alternatively or
additionally, controller 130 controls respiration over the entire sleep
period so as to control the probability of certain respiratory events
during the period. For example, to reduce the probability of snoring by
between 30%-70%, such as by about or more than 40%, 50% or 60% during a
sleep period. Controlling the probability of certain respiratory events
can be achieved by instructing odor dispersion at predefined time
periods, which may or may not be connected to detections by detectors
140.

[0138] In addition, controller 130 may control respiration according to a
desired reduction is snore rate and instruct odor dispersion accordingly.
For example every second snore leads to odor dispersion or every second
odor dispersion is with a different odorant.

[0139] In some embodiments, the inputs received from detector 140 may
refrain the controller from commanding odor dispersion, even if such
dispersion is applicable according to a time schedule. For example, if
the user did not reach a slow wave sleep (SWS), the controller may
refrain from instructing odor dispersion.

[0140] In some embodiments, when reservoir 105 includes more than one
odor, controller 130 determines at 320 which odor or which type of odor
should be generated. Different odors may be instructed responsive to
different respiratory events. For example, snoring may lead to the
generation of pleasant odors while breathing suspension may lead to the
generation of unpleasant odors. In addition, yet another odor may be
generated if no respiration event was detected. Alternatively, the odors
are randomly chosen. Alternatively or additionally, odors are generated
according to a pre-programmed sequence of odors. Optionally, the user may
manually set an odor or group of odors that may be generated. Optionally,
adaptation to odor is also taken into account when selecting an odor. For
example, a different odor than the last odor dispersion may be selected.

[0141] At 330 the dose (or concentration) of odor is optionally
determined. Different doses may be determined responsive to different
respiratory events or responsive to repeated respiratory events. For
example, if two breathing suspensions occur in a relatively short time
frame, a greater dose of odor dispersion may be determined.
Alternatively, the dose of odor is constant or a sequence of odor dose is
pre-programmed. Optionally, adaptation to odor is also taken into account
when determining odor dose. For example, greater doses may be determined
at repeating dispersions. Alternatively or additionally, the dose of odor
is pre-determined

[0142] Controller 130 then optionally determines the time period of
dispersion at 340. The time period may relate to time between odor onset
and offset or to a number of breathings between odor onset and offset.
Optionally, the number of breathings relates to a number of shallow or
heavy breaths, for example, only heavy breaths are taken into account
when measuring time period.

[0143] The time period may be determined responsive to the respiratory
event or may be randomly defined. The determined time period optionally
applies to a single odor dispersion. Alternatively, the determined time
period applies to a sequence of odor dispersions and the time period is
not re-defined for every dispersion. Alternatively, the time period of
odor dispersion is fixed or set by a user or practitioner and is not
determined by the controller. Alternatively, the time period of odor
dispersion is constant or a sequence of time periods is pre-programmed.

[0144] Odor dispersions may be all of the same length or of different
length. Optionally, each odor dispersion occurs for between 5-30 seconds,
for example for 5, 10 or 20 seconds. Optionally, each odor dispersion
occurs for between 3-8 breathings, such as for 5 or 6 breathings.
Optionally, the length of odor dispersion also depends on the volume of
odor dispersed.

[0145] Device 100 further optionally includes a learning module 180
adapted to monitor the respiratory patterns of the sleeper and learn
reactions to odor dispersions. In some embodiments, learning module 180
includes a table 185 with odorants and their effect on the sleeper's
respiration and/or arousal, optionally, according to sleep stage. Table
185 may further include dose of odorant, time period of dispersion and/or
sleeper's adaptation to odorant. Table 185 may be updated every
predefined number of odor dispersions or after an entire sleep period.

[0146] In some embodiments, learning module 180 provides inputs to
controller 130 and affects determinations made in any of 320-340.
Learning module 180 may comprise a number of rules on odor dispersion
from which it can choose to output to controller 130.

[0147] For example, if table 185 indicates that ammonium sulfide prevents
an apnea event, a rule of lavender dispersion, optionally including dose
and/or time of dispersion, to may be output to controller 130. For
example, if table 185 indicates that a lavender provides arousal
responses, module 180 may send a rule indicating that lavender should not
be dispersed. For instance if table 185 indicates that a specific dose of
odor is insufficient to change a respiratory pattern of the sleeper,
learning module 185 may send a rule indicating that a greater dose of
odor should be dispersed.

[0148] Learning module 185 may also affect a longer respiration control,
for example, a sequence of odor dispersions or sleep periods. For
example, learning module may indicate the start of an odor dispersion at
a small dosage and monitor the effect on respiration. If the desired
effect was not achieved, the learning module may indicate a greater
dosage and so on and so forth till the desired effect is achieved. The
same may be performed with different odorants or type of odors.

[0149] At 350, controller 130 instructs odor dispersion and generation in
view of the determinations made in 320-340.In some embodiments,
controller 130 is adapted to control the device in accordance with a
limited number of predefined operation options. Optionally the operation
options are manually adjustable by the user. For example, the device may
include 5 different options for time of dispersions and 3 options for
odors which are chosen by the user.

[0150] Controller 130 may be further connected to a communication unit
150. In some embodiments, upon activation of device 100, the user is
logging in at a practitioner or medical center using communication unit
150, for monitoring respiration and/or odor affect on the sleeper. In
some embodiments, the connection by communication unit 150 may call for a
physician or ambulance when necessary. Optionally, controller 130 is also
adapted to instruct activation of an alarm 160 which may cause arousal of
the sleeper or people in the vicinity of the sleeper. Optionally, for
example in devices which physically contact the sleeper, a vibrator is
provided instead or in addition to the alarm. Optionally, the device is
automatically turned off when the alarm is activated.

[0151] Device 100 further includes a power source 170 adapted to provide
power to the elements of device 100. Power source 170 is optionally a
battery which may be recharged. Optionally, power source 170 is purely
mechanical, such as a wind-up device where a mainspring is tightened for
activation. Other power sources known in the art may be used in
accordance with exemplary embodiments of the invention.

[0152] A timer 180 is optionally also provided for setting the operation
of the device. to Alternatively, an on/off switch is provided.
Alternatively, odors are automatically dispersed when events, such as
respiration events or sleep stages, are detected by one or more detectors
140.

[0153] Device 100 optionally further includes a display to display the
status of odor dispersions and/or the monitored detections by detectors
140. Optionally, the device also includes an input panel where the user
can input the desired frequency, odorant and/or dosage of odor to be
dispersed and/or characteristics to be measured or detected. Optionally,
the device also has a remote control.

[0154] Although the connections of the elements of device 100 are shown in
the figure, wireless connection may be used in exemplary embodiments of
the invention. For example, in order to provide a small device which can
fit as a nose clip, some of the elements of device 100 are optionally
positioned at a distance, optionally using wireless connection.

[0155] In some embodiments, a unit 125, including reservoir 105, odor
generator 110 and nozzle 120 is positioned near the nose of the sleeper,
while the rest of the device elements may be positioned further away from
the sleeper, for example in another room or a few meters away, such as 1
or 2 meters. Optionally, unit 125 includes only nozzle 120 which is
connected by a long tube to the rest of the device. Placing unit 125 away
from the rest of the device may assist in avoiding noise or lights (LEDs)
of the device to affect arousal or wake-up of the sleeper.

[0156] Optionally, one or more detectors 140 are also provided in unit
125. Optionally, some of detectors 140 are positioned in unit 125, while
other detectors are separately provided. For example, a sound detector
may be positioned near the nose of the sleeper while a respiratory
movement detector will be positioned beneath the mattress or bed sheet.
In some embodiments, controller 130 is also included in unit 125.

[0157] FIGS. 2A-2C are exemplary embodiments of device 100 (or unit 125)
integrated near the nose of a sleeper.

[0158] FIG. 2A illustrates device 100 in a bed pillow. In the embodiment
of FIG. 2A, the odorant is liquid or volatile. Optionally, device 100
comprises a cover which prevents the odorant from reaching the user, when
no odor dispersion is instructed.

[0159] FIG. 2B illustrates device 100 as a nose-ring. In the embodiment of
FIG. 2B, the odorant is optionally dispersed as an air puff.
Alternatively, device 100 continuously to blows air and a block of
odorant is embedded in the airflow when dispersion is instructed.

[0160] FIG. 2C illustrates device 100 in the form of a bed lamp. In the
embodiments of FIG. 2C, the odorant may be dispersed as an air puff or as
a liquid. Optionally, odor is evaporated using an electrical heater.
Optionally, the device includes a tube that is attached to the nose of
the sleeper where the odorants will be released. The tube is optionally
connected such that it does not move during sleep, for example by being
attached to the back of the sleeper's head.

[0161] FIG. 4 is a flowchart of a method 400 for respiration control in
accordance with some embodiments of the invention.

[0162] At 410 a user consults a practitioner following complaints on sleep
disorders. The complaints may be complaints by the user's surrounders,
such as snoring or complaints by the user himself, such as frequent
arousals. Optional, the complaints relate to medical state of the user,
such as apnea or any other breathing disorder.

[0163] At 420, the practitioner determines that respiration control during
sleep is required in order to aid the user. Optionally, the practitioner
instructs a treatment by odor dispersion. Alternatively, the practitioner
first instruct other treatment means, such as for example sleep-up for
apnea treatment, and instructs odor treatment only after other treatments
have failed. Optionally, the practitioner instructs respiration control
as described with respect to method 300 above.

[0164] In some embodiments, it is determined that a treatment of a certain
time period is necessary. In other embodiments, no time period for the
treatment is determined and the treatment is ongoing, optionally, for
life.

[0165] An odor dispersion device is provided at 430. Optionally, device
100 is provided for odor dispersion. Alternatively, other odor dispersion
means known in the art may be used.

[0166] Odors for dispersion are selected at 440. In some embodiments,
odors are selected after a survey of the effect of the odor on the user's
respiration. For example, a plurality of odors are inhaled by the user
and the user's respiration response thereto is measured. Optionally,
odors which provide respiratory rejection type responses, such as
decreased inhalation and/or decreased exhalation, are used. For example,
for apnea treatment, any of vanillin, lavender, ammonium sulfide and/or
vetiver may be used. Optionally, the pleasantness of the odor to the user
and/or to others sleeping near the user are also taken into account.

[0167] In some embodiments, only odors which do not induce arousal or
wake-up responses are selected. Optionally, only olfactory or mild
trigeminal odors are selected. Optionally, one or more of the above
criteria are taken into account when selecting odors.

[0168] In some embodiments, a table, such as table 185 described above,
with odorants and their effect on the user's respiration and/or arousal
is created, optionally, according to sleep stage. The table then assists
in selecting odorants for dispersion responsive to physiological
measurements, such as respiration events and/or sleep stage. In some
cases, a user acquires an odor dispersion device without consulting a
practitioner.

[0169] At 450 the frequency and dose of odor dispersion is selected.
Optionally, a sequence of odor dispersion is selected. Alternatively,
each odor dispersion is separately selected according to physiological
measurements made and/or according to information in the table.

[0170] The device is activated at 460, optionally, at the sleep time of
the user.

[0171] Influence of the odor dispersions are monitored at 470. The
influence on several physiological characteristics may be monitored. For
example, overall respirations, nasal and oral respirations can be
measured by respiratory belts or by a nasal masks. Arousal responses may
be measured according to measurements of EEG and EMG by electrodes. Also
Electroocculogram, and Electrocardiogram (ECG) may be measured using
electrodes. Alternatively arousal responses may be measured using EMG or
EKG alone. Optionally also Blood oxygation (Sp02) is measured by finger
clip sensor. Optionally, sleep stage is detected by electrodes or a helm.
Optionally, the users wears a cap for measuring physical characteristics
and/or disperse odors.

[0172] At 470 the practitioner is consulted again to discuss the influence
of the treatment. The table and measured physiological characteristics
are examined. 440 and 450 may be updated in view of the results examined.

[0173] In some embodiments, odor influence is monitored during the sleep
period and odorant, dose and/or dispersions frequency and/or dose may be
changed in view of the monitored characteristics. Alternatively,
influence is examined after one or more sleep to periods, for example
after between 20-40 odor dispersions. Odorant, dose and/or dispersions
frequency and/or dose are then optionally changed for the next sleeping
period.

[0174] For example, if it is determined that vetiver provides arousal
responses, vetiver may be removed from the odorants used. Also, if it is
determined that vanillin has a better effect on stage 2 sleep, vanillin
may be used when stage 2 is reached. In addition, if it is determined
that after 2 similar odor dispersions the user adapts to the odorant and
a lower or no respiratory response is received, odors may be changed
after every dispersion.

[0177] The term "consisting essentially of" means that the composition,
method or structure may include additional ingredients, steps and/or
parts, but only if the additional ingredients, steps and/or parts do not
materially alter the basic and novel characteristics of the claimed
composition, method or structure.

[0178] As used herein, the singular form "a", "an" and "the" include
plural references unless the context clearly dictates otherwise. For
example, the term "a compound" or "at least one compound" may include a
plurality of compounds, including mixtures thereof.

[0179] Throughout this application, various embodiments of this invention
may be presented in a range format. It should be understood that the
description in range format is merely for convenience and brevity and
should not be construed as an inflexible limitation on the scope of the
invention. Accordingly, the description of a range should be considered
to have specifically disclosed all the possible subranges as well as
individual numerical values within that range. For example, description
of a range such as from 1 to 6 should be considered to have specifically
disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2
to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within
that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of
the breadth of the range.

[0180] Whenever a numerical range is indicated herein, it is meant to
include any cited to numeral (fractional or integral) within the
indicated range. The phrases "ranging/ranges between" a first indicate
number and a second indicate number and "ranging/ranges from" a first
indicate number "to" a second indicate number are used herein
interchangeably and are meant to include the first and second indicated
numbers and all the fractional and integral numerals therebetween.

[0181] It is appreciated that certain features of the invention, which
are, for clarity, described in the context of separate embodiments, may
also be provided in combination in a single embodiment. Conversely,
various features of the invention, which are, for brevity, described in
the context of a single embodiment, may also be provided separately or in
any suitable subcombination or as suitable in any other described
embodiment of the invention. Certain features described in the context of
various embodiments are not to be considered essential features of those
embodiments, unless the embodiment is inoperative without those elements.

[0182] Various embodiments and aspects of the present invention as
delineated hereinabove and as claimed in the claims section below find
experimental support in the following examples.

EXAMPLES

[0183] Reference is now made to the following examples, which together
with the above descriptions illustrate some embodiments of the invention
in a non limiting fashion. The inventors of the present application made
the following experiment of odor influence on respiration during sleep.

Example 1

[0184] Participants

[0185] Forty-five healthy subjects (21 women and 24 men) ranging in age
from 23 to 36 years (M=27.2±2.28 years) participated in the study
after providing informed consent to procedures approved by the Committee
for Protection of Human Subjects at the

[0186] Assuta hospital. Subjects were screened for abnormal sleep habits
and history of nasal insults. Exclusion criteria were irregular breathing
pattern, insufficient sleeping time, and use of medication or
demonstration of sleep apnea syndrome with respiratory disturbance index
>10. Nine subjects failed to meet the study criteria and were
therefore excluded from analysis.

[0191] Odorants were delivered with a computer-controlled air dilution
olfactometer built according to principals described in Sobel et al.
1997; Johnson and Sobel 2007 which are incorporated herein by reference.
Room air (3 Liter per minute) was mixed with the odorized air (3 liter
per minute), resulting in odor concentration of 50%. The odorant line
culminated at a small nasal mask that was subserved by a vacuum line
pulling at the same rate of airflow. This provided an odor environment at
the nose where odorant onset and offset occurred within 2 and 260 ms,
respectively, with no visual, auditory, tactile, humidity, or thermal
cues as to the alteration. In other words, the odorant stimulus was not a
puff of air but rather a block of odorant embedded within an airflow that
was constant for the duration of the study. The olfactometer itself was
located in a room adjacent to the sleep room, and only the airflow tubing
crossed into the sleep room via a wave guide within the stainless
steel-coated wall. This provided additional separation from any possible
visual or auditory stimulation associated with the olfactometer (e.g.,
LEDs on its front panel, etc.).

[0192] Polysomnography and Sleep Scoring

[0193] Physiological measurements were recorded using a Power-Lab 16SP
Monitoring System (ADInstruments) running off a Macintosh G4 computer
using a sampling rate of 1000 Hz and a 50-Hz notch filter to remove
electrical artifacts. For all measures dependent on electrodes, the scalp
surface was cleaned with mild abrasive gel (Nuprep gel, Aurora) in order
to assist in lowering impedance at the electrode site. For pasted to
electrodes on the rest of the body, the skin surface was also first
cleaned with alcohol. The following measures were recorded:

[0194] Electroencephalogram (EEG) was obtained through 2 circular
electrodes (0.9 mm diameter) that were located at positions C3 and C4
according to the 10-20 system and were referenced to electrodes on the
opposite mastoids (A2 and A1, respectively). Signals were amplified using
a preamplifier (Octal Bio Amp ML138, ADInstruments).

[0197] Electrocardiogram (ECG) was obtained through 3 circular Ag/AgCl
conductive adhesive electrodes (0.9 cm diameter). Electrodes were placed
on both the left and the right sides of the abdomen, and a ground
electrode was placed on the left foot. Signals were amplified using a
preamplifier (Bio Amp ML132, ADInstruments).

[0198] Blood oxygination (SpO2) was measured with an oxymeter (MLT321 SpO2
Finger Clip Sensor, ADInstruments) embedded within a finger clip placed
on the left index finger.

[0200] Nasal and Oral respiration was measured using separate
pneumotachometers (high-sensitivity flowmeter model #4719, Hans Rudolph,
Inc.) that were attached in line with the vent ports of the mask. The
pneumotachometer differential pressure was measured and converted to a
voltage signal using a spirometer (ML141, ADInstruments) that delivered
the voltage to the instrumentation amplifier.

[0201] Sleep stages were scored off-line according to the R and K criteria
(Rechtschaffen and Kales 1968). An abrupt change in EEG frequency and/or
brief increase in EMG amplitude for more than 3 s or over 15 s were
classified as arousal or wake-up, respectively, as defined by the atlas
task force of the American Sleep Disorder Association (AAoSMTF 1992). An
arousal or wake-up was attributed to the odor stimuli if they occurred
anywhere from odor onset to 30 s following odor offset (Stuck et al.
2007). Scoring for respiratory events, apnea and hypopnea, were according
to the American Academy of Sleep Medicine (AAoSMTF 1999).

[0202] The effects of odorants on 4 breath parameters were tested: breath
mean airflow velocity, breath maximum airflow velocity, breath volume,
and breath duration. Breath volume was calculated by the trapezoidal
Reimann sum method (Johnson et al. 2006). Breaths were aligned in time by
setting the point at which the breath passed from the expiratory phase to
the inspiratory phase as time 0.

[0203] Any of the above measurements can be used according to exemplary
embodiments of the present invention.

[0204] Procedures

[0205] Subjects arrived at the olfaction sleep laboratory at a
selfselected time, based on their usual sleep time, typically
˜11:00 PM. After providing informed consent, subjects were led to
the experimental room. This room was coated in stainless steel in order
to prevent ambient odor adhesion and supplemented with high-efficiency
particulate air and carbon filtration to further assure an odor-free
environment. Subjects first rated the intensity and pleasantness of the
odorant using a visual analog scale (VAS). The VAS consisted of a line
without any tick marks (14 cm long), with only the extremes marked as
reflecting "very" or "not at all" (in Hebrew). After fitting of the
polysomnography devices and assuring a comfortable positioning within the
bed, subjects were left alone in the darkened room to be observed from
the neighboring control room via IR video camera and 1-way observation
window.

[0206] The experimenters observed the real-time polysomnography reading,
and 20 min after they determined that the subject had entered stage 2
sleep, they initiated the experimental protocol that from this point on
was computer controlled. Every 9, 12, or 15 min (randomized), the
olfactometer generated a 5-, 10-, or 20-s (randomized) odor to stimulus.
This resulted in 21-37 odorant presentations per night. Upon spontaneous
morning wake-up, subjects again rated the intensity and pleasantness of
the odorant and were then debriefed, paid, and released.

[0207] Statistics

[0208] The obtained ratings for the respective odorant qualities were
analyzed to test for differences between odorants in perception before
and after the night. Odorant ratings were compared using a repeated
measures analysis of variance (ANOVA) within Statistica software
(StatSoft, Inc.). The ANOVA analysis was followed by contrast t-tests to
test the difference between each 2 odorants. A P value of less than 0.05
was considered significant.

[0209] The number of arousals attributed to an odor divided by the total
number of odor presentations was the "odor arousal frequency." The number
of arousals attributed to an odorless baseline period (containing an
equal flow of clean air) divided by the total number of odor
presentations was the "baseline arousal frequency." Wake-up frequencies
were calculated in the same manner. Frequencies were calculated for each
subject and for each sleep stage. Frequencies of arousals and wake-ups
were compared between and across sleep stages per odorant in a repeated
measures ANOVA.

[0210] Averages of respiration measurements for inhalation, exhalation,
and inhalation/exhalation ratio in the 30 breaths before odor onset were
compared with the averages of respiration measurements for inhalation,
exhalation, and inhalation/exhalation ratio for each one of 6 breaths
after odor onset across sleep stages per odorant and for all odorants
together. This analysis was corrected for the 6 comparisons using a
Bonferroni correction. Respiratory measurements were compared between
sleep stages per odorant in a repeated measures ANOVA.

[0217] The odorants vanillin (n=12 after exclusions), lavender oil (n=13
after exclusions), and ammonium sulfide (n=5 after exclusions) were
initially tested. For vanillin, there was no effect of odor on wake-up
[F(1,11)=2.23, P<0.16], regardless of sleep stage [F(2,22)=0.009,
P<0.99], and no effect of odor on arousal [F(1,11)=2.93, P<0.12],
regardless of sleep stage [F(2,22)=1.98, P<0.16]. For lavender oil,
there was no overall effect on arousal [F(1,12)=0.13, P<0.72], with a
sleep stage effect [F(2,24)=8.68, P<0.001] reflecting increased
arousal in stage 2 sleep compared with other sleep stages.

[0218] There was a trend toward an effect on wake-ups [F(1,12)=3.53,
P=0.084], whereby lavender oil lowered the frequency of wake-ups, and a
significant interaction between wake-up rates and sleep stage
[F(2,24)=3.37, P<0.03], reflecting increased wake-up in stage 2 sleep
in the presence of odor compared with other sleep stages and baseline.
For ammonium sulfide, there was no effect of odor on wake-up [F(1,4)=1.0,
P<0.37], regardless of sleep stage [F(2,8)=1.0, P<0.41], or arousal
[F(1,4)=0.56, P<0.49], regardless of sleep stage [F(2,8)=0.45,
P<0.64] (FIG. 6, Table in FIG. 7). to Consistent with these results,
ECG and blood oxygenation measurements were not influenced by odor
presentation [ECG levels at baseline=57.96±7.34 beats per minute
(BPM), ECG levels after odor presentation=58.04±7.37 BPM;
F(1,26)=0.23, P<0.6; blood oxygenation at baseline 97.04±1.22,
blood oxygenation after odor presentation 97.06±1.23; F(1,23)=0.35,
P<0.56]. The subjects' blood oxygenation levels during wake-up were
97.66±1.12% and total night average was 96.84±1.56%.

[0219] Odors Influenced Respiratory Patterns in Sleep

[0220] The inhale/exhale volume ratio was significantly smaller following
odor presentation in comparison to baseline for vanillin (n=12 following
exclusions), ammonium sulfide (n=5 following exclusions), and lavender
oil (n=13 following exclusions) across all sleep stages (FIG. 8, Table in
FIG. 9). This effect was most pronounced for the first breath following
odorant onset [F(1,35)=384.51, P<0.0001] and then decreased in a
nearly linear fashion until it was on the border of significance
(Bonferroni corrected) at the sixth breath after odorant onset
[F(1,35)=7.87, P<0.0081] (FIG. 8). For all odorants, there was no
difference in respiration volume ratio across sleep stages [vanillin
F(2,22)=2.61, P<0.1; lavender oil F(2,24)=3.00, P<0.07; ammonium
sulfide F(2,8)=0.24, P<0.79].

[0221] Breath inhalation and exhalation volume were also separately
examined. Inhalation volume decreased significantly following odor onset
for all 6 breaths after odor onset across the 3 odorants [all
F(1,29)>14.2, P<0.0007]. Exhalation volume increased significantly
in comparison to baseline for only the first breath after odor onset
across the 3 odorants [F(1,29)=9.36, P<0.005] (FIG. 10, Table in FIG.
9).

[0222] The influence of odors on respiratory patterns in sleep reflected a
temporary increase in net exhalation.

[0223] The after odorant decrease in nasal inhalation and increase in
nasal exhalation may have resulted from 2 alternative scenarios. In the
first scenario, the odorant-induced temporary increase in the net nasal
exhalation may have relied on the lung's air reserve.

[0224] The second alternative is that, although oral respiration typically
reflects only; 4% of overall respiration in sleep (Fitzpatrick et al.
2003), the odorant may have changed the balance between nasal and oral
breathing such that oral inspiration increased. Under this scenario, the
increase in nasal exhalation reflected an increase in oral inspiration
rather to than the exhalation of air stored in the lungs. The above data
could not discriminate between these alternatives because it relied on
accurate measurement of nasal respiration alone. An additional control
group of 10 subjects were studied using the odorant vetiver oil that in
addition to the nasal mask were fitted with an oral mask in order to
accurately measure oral and nasal respiration simultaneously.

[0225] Regarding the effects of the odorant on sleep, the results with
vetiver oil were similar to those with the 3 previous odorants. Seven
subjects had full polysomnography data, and in these, there was a
significant decrease in arousal frequency following odorant presentation
[F(1,6)=28.13, P<0.001], regardless of sleep stage [F(2,12)=0.95,
P<0.41], and no change in wake-up frequency [F(1,6)=1.29, P<0.29],
regardless of sleep stage [F(2,12)=0.86, P<0.45] (FIG. 6, Table in
FIG. 7).

[0226] Regarding the effects of the odorant on respiration, only 0-18% of
overall after odorant respiration was oral, and it was indeed nasal
respiration that carried the previously observed effects, whereby the
odorant reduced inhale/exhale volume ratio across all sleep stages (FIG.
8, Table in FIG. 7) (1 subject had a stuffed nose and was therefore
excluded from this analysis). In analyzing the nasal respirations, this
effect was significant for 3 consecutive breathes following odor onset
[all F(1,5)>22.34, P<0.006], regardless of sleep stage
[F(2,10)=1.127, P<0.36]. In all 4 odorants, there was a ˜30%
change in inhale/exhale volume ratio in the first breath following odor
onset (FIG. 11). Similar to the other odorants, the effects in vetiver
oil were a result of a decrease in inhalation and increase in exhalation
volume that remained significant for 2 breaths following odor onset [all
F(1,5)>11.02, P<0.02]. In other words, the change that was found in
respiration pattern during sleep reflected a temporary increase in net
nasal exhalation that relied on the lung's air reserve.

[0227] Although all odorants tested had a similar type of influence on
respiration, the results were combined using vetiver oil with those using
ammonium sulfide in order to allow a better test for any influence of
odorant valence on respiration in sleep. This combination generated 1
group of 11 subjects tested with unpleasant odorants (vetiver oil and
ammonium sulfide) and 2 separate groups of 12 (vanillin) and 13 (lavender
oil) subjects tested with pleasant odorants. No difference in the effect
size of the inhale/exhale volume ratio across the odorants [all
F(2,33)<2.23, P>0.12] were found, and follow-up tests revealed no
significant differences in either inhale or exhale change across valences
[all F(2,33)<1.37, all P>0.2].

[0228] To further examine the influence of odor valence on respiratory
volume ratio, comparison was made between pleasant odorants (vanillin and
lavender oil) and the unpleasant odorants (vetiver oil and ammonium
sulfide). It was found that the inhale/exhale volume ratio was not
influenced by valence [all F(1,32)<5.59, P=not significant following
correction].

[0229] Moreover, to further examine the influence of trigeminality on
respiratory volume ratio, comparison was made between mildly trigeminal
odorants (lavender oil and vetiver oil) and pure olfactants (vanillin and
ammonium sulfide). It was found that the inhale/exhale volume ratio was
greater for pure olfactants only at the fourth breath after odorant onset
[pure olfactants=0.15±0.08, mild trigeminal odors=0.07±0.05;
F(1,32)=13.1, P<0.001].

[0231] One male participant at the age 22 participated in this study. The
participant suffered from snoring but did not suffer from apnea. Two
blends of odorants were used: undiluted Rotten Fish (Sensale, Ramat-Gan,
Israel) and undiluted Toilet deodorizer. The dispersion of the odors
lasted three second and occurred every 25 second to 5 minutes in a
randomized order. 3 liters of odorant were mixed with 3 liters of air,
resulting in odor concentration of 50%.

[0232] The results of this study show that repeated dispersion of odor
during a sleep period significantly reduced snoring. FIG. 12 shows the
probability of snoring with and without odor dispersion. The probability
of snoring of the participant in the base line was 90% and repeated odor
dispersion reduced the probability to about 50%.

[0233] FIG. 13 illustrates respiratory cycles of the participant, where
the "noise" at the respirator cycles reflect snoring. The line below the
graph reflects odor dispersion. It was shown that there was no snoring
for the first breath after odor dispersion of both rotten fish and
perfume, i.e., both pleasant and unpleasant odors.

[0234] Although the invention has been described in conjunction with
specific embodiments thereof, it is evident that many alternatives,
modifications and variations will be apparent to those skilled in the
art. Accordingly, it is intended to embrace all such alternatives,
modifications and variations that fall within the spirit and broad scope
of the appended claims.

[0235] All publications, patents and patent applications mentioned in this
specification are herein incorporated in their entirety by reference into
the specification, to the same extent as if each individual publication,
patent or patent application was specifically and individually indicated
to be incorporated herein by reference. In addition, citation or
identification of any reference in this application shall not be
construed as an admission that such reference is available as prior art
to the present invention. To the extent that section headings are used,
they should not be construed as necessarily limiting.

Patent applications by YEDA RESEARCH AND DEVELOPMENT CO. LTD.

Patent applications in class Control means responsive to condition other than user's airway pressure

Patent applications in all subclasses Control means responsive to condition other than user's airway pressure